【Key Responsibilities】
• Manage day-to-day operational aspects of Phase I–III clinical trials from study start-up through closeout.
• Develop maintain study timelines, project plans, trial tracking tools.
• Coordinate activities among CROs, clinical sites, vendors, internal stakeholders.
• Monitstudy progress identify risks, implementing mitigation strategies as needed.
• Review execute according to essential study documents, including protocols, informed consent forms, monitoring plans, study manuals.
• Oversee CRO site activation, enrollment, patient retention, data collection activities.
• Ensure compliance with ICH-GCP, FDA, EMA, applicable regulatory requirements.
• Have experience in managing study budgets, forecasts, review of vendcontracts.
• Lead study team meetings provide regular updates to senimanagement.
• Review monitoring reports, protocol deviations, CAPA plans.
• Support regulatory submissions, ethics committee approvals, inspection readiness activities as needed.
• Collaborate with Data Management, Biostatistics, Medical Monitoring, Safety, Regulatory Affairs, Clinical Operations teams.
• Contribute to process improvements implementation of best practices across clinical programs.
【Qualifications】
• Bachelors degree in the Sciences, Nursing, Pharmacy, Public Health, related field.
• Approximately 3-5 years of clinical research experience, including experience managing clinical studies.
• Strong understanding of ICH-GCP guidelines clinical trial regulations.
• Experience working with CROs external vendors.
• Knowledge of CTMS, EDC, eTMF, clinical trial systems.
• Excellent project management, communication,ganizational skills.
• Ability to manage multiple priorities in a fast-paced environment.
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